Orthodontic RetentionNCT05738889

Comparative Evaluation of Salivary Bisphenol-A Levels in Patients With Fixed Lingual, Hawley and Vacuum-formed Retainers

An observational study of Orthodontic Retention, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study; to measure the BPA release amount of fixed lingual retainers applied with Bis-GMA-containing composite , fixed lingual retainers applied with Bis-GMA-free composite, vacuum-formed and hawley retainers which used for retention after orthodontic treatment to evaluate whether they are risk factors… Read more about this study

Who is it for?: Ages 10 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Orthodontic Retention
What is being tested?: Fixed lingual retainers applied with Bis-GMA containing composite, Fixed lingual retainers applied with Bis-GMA-free composite and Vacuum-formed retainers
Type of treatment: Pill or oral medicine, Medical device
How many people: 120 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 28 Jul 2021to 4 Dec 2022
How long will I take part?: 1 Month
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: Men and women patients aged between 10-18 years who have completed orthodontic treatment

Who may be able to join

be between the ages 10-18
absence of any systemic disease
good oral hygiene
completion of orthodontic treatment
non smoker
Not working in jobs where they will be exposed to chronic BPA release, such as gas station construction site or acrylic related jobs

Who cannot join

be under 10 years or over 18 years
any systemic disease
poor oral hygiene
ıncomplete orthodontic treatment
being a smoker
working in jobs where they will e exposed to chronic BPA release, such as gas station construction site or acrylic related jobs

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Aydın Adnan Menderes University Faculty of Dentistry
Aydin, Efeler, 09000

Other trials in Turkey (Türkiye)

About this study

Study method and data collection techniques: In this study, individuals will be selected from the patients who will be treated at Aydın Adnan Menderes University Faculty of Dentistry, Department of Orthodontics between July 2021 and July 2022, whose orthodontic treatment will be completed. These patients will be randomly divided into four groups according to the type of retention appliance to be chosen: those who are applied a fixed lingual retainer with a bis-GMA-containing composite, those with a fixed lingual retainer with a bis-GMA-free composite, those with an vacuum formed retainers, and those with a hawley retainers. After the debonding of the fixed attachments at the end of the treatment appointment, the retention appliances will be applied 1 day later so that BPA, which is released from the resin adhesives used to bond the attachments, does not affect the study data. Saliva samples will be taken from the patients before the appliance is inserted, 1 hour, 7 days and 30 days after the appliance is inserted.

Read the detailed description

Patients who are scheduled to complete their orthodontic treatment between July 2021 and July 2022 and will be debonded will be included in the study. Inclusion criteria for the study; not to have any systemic diseases, not to smoke, not to work in jobs where they will be exposed to chronic BPA release, such as gas station-construction site or acrylic-related jobs. Selected patients will be randomly divided into four groups. Randomization will be done through the website www.random.org. Fixed lingual retainer applied with composite containing Bis-GMA will be applied in the first group, fixed lingual retainer applied with composite without Bis-GMA in the second group, vacuum formed retainers in the third group and hawley retainers in the fourth group. 120 patients, including 30 individuals in each group, will be included in the study. The number of men and women in each group will be equal. Patients who have undergone debonding will be given an appointment to wear retention appliances one day later. Patients will be advised to brush their teeth routinely, including the appointment day, and not to consume any food or drink at least 2 hours before the application. In addition, due to the effect of many drugs on salivary secretion, if patients use drugs, they will be told to take them at least 8 hours before the application. Saliva samples for BPA release will be taken before appliance insertion, 1 hour after, 7 days and 30 days after insertion. Samples taken will be stored in polypropylene tubes. All samples taken will be stored at -80 degrees until analysis. The sample will be processed by mixing 5ml saliva with an equal amount of ethanol and vortexing it. It will be centrifuged at 3000 rpm for 15 minutes. The ultimately processed sample will be injected into the instrument and analyzed by liquid chromatography.

Conditions: Orthodontic Retention
Being tested: Fixed lingual retainers applied with Bis-GMA containing composite, Fixed lingual retainers applied with Bis-GMA-free composite, Vacuum-formed retainers, Hawley retainers
Keywords: Orthodontic retention, Bisphenol-A, lingual retainer, Hawley retainer, Vacuum formed retainer, essix plate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fixed lingual retainers applied with Bis-GMA containing compositeDevice
Also called Reliance Orthodontic Gel Etching Agent, Illinois, USA, American Orthodontics Brace Paste MTP primer, Wisconsin, USA, Reliance Orthodontic Bond-A-Braid, Illinois, USA, Reliance Orthodontic Flow Tain Low Viscosity W/TIPS, Illinois, USA
Bonding materials of fixed lingual retainers applied with Bis-GMA containing composite
Fixed lingual retainers applied with Bis-GMA-free compositeDevice
Also called Reliance Orthodontic Gel Etching Agent, Illinois, USA, Reliance Orthodontic Bond-A-Braid, Illinois, USA, GC Ortho Connect Flow, Tokyo, Japan
Bonding materials of fixed lingual retainers applied with Bis-GMA-free composite
Vacuum-formed retainersDevice
Also called Supplies Atmos Thermoforming Material 0.40 inç, USA, Dentsply Sirona, USA
vacuum-forming machine and vacuum formed plates
Hawley retainersDevice
Also called Dentaurum Orthocryl, Ispringen, Germany
Acrylic based hawley retainers

Study groups in NCT05738889
Study group	Role	What they receive
Group 1: Patients with fixed lingual retainers applied with Bis-GMA containing composite		In the maxilla and mandible, the lingual surfaces of the anterior six teeth, including the canines, were roughened and bonded by applying 37.5% phosphoric acid for 30 seconds. Then, the retainer wire was adhered to the lingual surfaces of the teeth between the canine-canines in the maxilla and mandible, where a fixed lingual retainer will be applied, with a flowable composite adhesive containing Bis-GMA, with 10 seconds of illumination for 60 seconds for each tooth. Receives: Device: Fixed lingual retainers applied with Bis-GMA containing composite
Group 2: Patients with fixed lingual retainers applied with Bis-GMA-free composite		The lingual surfaces of the anterior six teeth, including the canines, in the maxilla and mandible were roughened by the application of 37.5% phosphoric acid for 30 seconds. Since the applied composite system is one-stage, no additional bond application was done. Fixed lingual retainer wire was applied with a Bis-GMA-free flowable composite adhesive with 60 seconds exposure for 10 seconds for each tooth. Receives: Device: Fixed lingual retainers applied with Bis-GMA-free composite
Group 3: Patients with vacuum-formed retainers		Impressions were taken with alginate impression material from the maxilla and mandible of the volunteers whose treatment was completed, and a model was obtained with a hard cast. On the models obtained, vacuum formed retainers were prepared with a vacuum forming machine. The use and care instructions of vacuum formed retainers were explained to the patient orally. vacuum formed retainers were used by the patient for 22 hours. Receives: Device: Vacuum-formed retainers
Group 4: Patients with hawley retainers		Impressions were taken with alginate impression material from the volunteers in the Hawley retainers group and a model was obtained with hard plaster. Wire elements were made on the model obtained and the appliance was prepared from transparent acrylic material. After the leveling and polishing processes were completed, the hawley retainers was attached to the mouth. It is stated that the appliance is used for 22 hours in 1 day. The use and care instructions of the Hawley retainers are explained to the patient. Receives: Device: Hawley retainers

What is being measured

The primary outcome is the main question the study is designed to answer.

Bisphenol-A amount in saliva before applying a retainer with bis-GMA-containing composite
The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.
Measured: 1 day after debonding and before retention appliance to 1 month.
Bisphenol-A amount in saliva before applying a retainer with bis-GMA-free composite
The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.
Measured: 1 day after debonding and before retention appliance to 1 month.
Bisphenol-A amount in saliva before applying vacuum formed retainer
The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.
Measured: 1 day after debonding and before retention appliance to 1 month.
Bisphenol-A amount in saliva before applying hawley retainer
The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.
Measured: 1 day after debonding and before retention appliance to 1 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 20214 Dec 2022

First posted22 Feb 2023
Study start28 Jul 2021
Primary completion8 Nov 2022
Study completion4 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Orthodontic RetentionStudies of the same condition, open and under way.
More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 120 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT05738889
Sponsor's protocol ID: DHF-21010
Status last verified: Feb 2023
First submitted: 13 Feb 2023
Last updated: 24 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Raghavan AS, Pottipalli Sathyanarayana H, Kailasam V, Padmanabhan S. Comparative evaluation of salivary bisphenol A levels in patients wearing vacuum-formed and Hawley retainers: An in-vivo study. Am J Orthod Dentofacial Orthop. 2017 Mar;151(3):471-476. doi: 10.1016/j.ajodo.2016.07.022.
PubMed 28257731
Manoj MK, Ramakrishnan R, Babjee S, Nasim R. High-performance liquid chromatography analysis of salivary bisphenol A levels from light-cured and chemically cured orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):803-808. doi: 10.1016/j.ajodo.2018.02.008.
PubMed 30477778
Eliades T, Voutsa D, Sifakakis I, Makou M, Katsaros C. Release of bisphenol-A from a light-cured adhesive bonded to lingual fixed retainers. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):192-5. doi: 10.1016/j.ajodo.2009.12.026.
PubMed 21300247
Sasaki N, Okuda K, Kato T, Kakishima H, Okuma H, Abe K, Tachino H, Tuchida K, Kubono K. Salivary bisphenol-A levels detected by ELISA after restoration with composite resin. J Mater Sci Mater Med. 2005 Apr;16(4):297-300. doi: 10.1007/s10856-005-0627-8.
PubMed 15803273
Kang YG, Kim JY, Kim J, Won PJ, Nam JH. Release of bisphenol A from resin composite used to bond orthodontic lingual retainers. Am J Orthod Dentofacial Orthop. 2011 Dec;140(6):779-89. doi: 10.1016/j.ajodo.2011.04.022.
PubMed 22133942
Eliades T, Hiskia A, Eliades G, Athanasiou AE. Assessment of bisphenol-A release from orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2007 Jan;131(1):72-5. doi: 10.1016/j.ajodo.2006.08.013.
PubMed 17208109

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
Orthodontic Retainers, Tooth Mobility
Not yet recruiting
Digital vs Conventional VFR in Post-Orthodontic Retention
Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment)
Active, not recruiting
Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up
Dental Malocclusion, Stability
Not yet recruiting
3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
Orthodontic Relapse, Malocclusion
Not yet recruiting
The Effect of Full Versus Partial Coverage Thermoformed Retainers in Dual Retention With a Lower Bonded Retainer, on Periodontal, Orthodontic, and Patient-Reported Outcomes
Orthodontic Retention

All Orthodontic Retention trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Evaluation of Salivary Bisphenol-A Levels in Patients With Fixed Lingual, Hawley and Vacuum-formed Retainers
ClinicalTrials.gov ID: NCT05738889
Acronym / sponsor ID: DHF-21010
Conditions: Orthodontic Retention
Keywords: Orthodontic retention, Bisphenol-A, lingual retainer, Hawley retainer, Vacuum formed retainer, essix plate
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Aydin Adnan Menderes UniversityUniversity, hospital or other
Study start: 28 Jul 2021 (actual)
Primary completion: 8 Nov 2022 (actual)
Study completion: 4 Dec 2022 (actual)
First posted: 22 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Month
Number of arms: 4

Arm	Type	Receives
Group 1: Patients with fixed lingual retainers applied with Bis-GMA containing composite	–	Device: Fixed lingual retainers applied with Bis-GMA containing compositeIn the maxilla and mandible, the lingual surfaces of the anterior six teeth, including the canines, were roughened and bonded by applying 37.5% phosphoric acid for 30 seconds. Then, the retainer wire was adhered to the lingual surfaces of the teeth between the canine-canines in the maxilla and mandible, where a fixed lingual retainer will be applied, with a flowable composite adhesive containing Bis-GMA, with 10 seconds of illumination for 60 seconds for each tooth.
Group 2: Patients with fixed lingual retainers applied with Bis-GMA-free composite	–	Device: Fixed lingual retainers applied with Bis-GMA-free compositeThe lingual surfaces of the anterior six teeth, including the canines, in the maxilla and mandible were roughened by the application of 37.5% phosphoric acid for 30 seconds. Since the applied composite system is one-stage, no additional bond application was done. Fixed lingual retainer wire was applied with a Bis-GMA-free flowable composite adhesive with 60 seconds exposure for 10 seconds for each tooth.
Group 3: Patients with vacuum-formed retainers	–	Device: Vacuum-formed retainersImpressions were taken with alginate impression material from the maxilla and mandible of the volunteers whose treatment was completed, and a model was obtained with a hard cast. On the models obtained, vacuum formed retainers were prepared with a vacuum forming machine. The use and care instructions of vacuum formed retainers were explained to the patient orally. vacuum formed retainers were used by the patient for 22 hours.
Group 4: Patients with hawley retainers	–	Device: Hawley retainersImpressions were taken with alginate impression material from the volunteers in the Hawley retainers group and a model was obtained with hard plaster. Wire elements were made on the model obtained and the appliance was prepared from transparent acrylic material. After the leveling and polishing processes were completed, the hawley retainers was attached to the mouth. It is stated that the appliance is used for 22 hours in 1 day. The use and care instructions of the Hawley retainers are explained to the patient.

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Men and women patients aged between 10-18 years who have completed orthodontic treatment

Key inclusion criteria (6 listed)

be between the ages 10-18
absence of any systemic disease
good oral hygiene
completion of orthodontic treatment
non smoker

Key exclusion criteria (6 listed)

be under 10 years or over 18 years
any systemic disease
poor oral hygiene
ıncomplete orthodontic treatment
being a smoker

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fixed lingual retainers applied with Bis-GMA containing compositeAlso: Reliance Orthodontic Gel Etching Agent, Illinois, USA, American Orthodontics Brace Paste MTP primer, Wisconsin, USA, Reliance Orthodontic Bond-A-Braid, Illinois, USA, Reliance Orthodontic Flow Tain Low Viscosity W/TIPS, Illinois, USABonding materials of fixed lingual retainers applied with Bis-GMA containing composite	Device	Group 1: Patients with fixed lingual retainers applied with Bis-GMA containing composite
Fixed lingual retainers applied with Bis-GMA-free compositeAlso: Reliance Orthodontic Gel Etching Agent, Illinois, USA, Reliance Orthodontic Bond-A-Braid, Illinois, USA, GC Ortho Connect Flow, Tokyo, JapanBonding materials of fixed lingual retainers applied with Bis-GMA-free composite	Device	Group 2: Patients with fixed lingual retainers applied with Bis-GMA-free composite
Vacuum-formed retainersAlso: Supplies Atmos Thermoforming Material 0.40 inç, USA, Dentsply Sirona, USAvacuum-forming machine and vacuum formed plates	Device	Group 3: Patients with vacuum-formed retainers
Hawley retainersAlso: Dentaurum Orthocryl, Ispringen, GermanyAcrylic based hawley retainers	Device	Group 4: Patients with hawley retainers

Primary outcome

Bisphenol-A amount in saliva before applying a retainer with bis-GMA-containing composite
Time frame: 1 day after debonding and before retention appliance to 1 month.
The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.
Bisphenol-A amount in saliva before applying a retainer with bis-GMA-free composite
Time frame: 1 day after debonding and before retention appliance to 1 month.
The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.
Bisphenol-A amount in saliva before applying vacuum formed retainer
Time frame: 1 day after debonding and before retention appliance to 1 month.
The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.
Bisphenol-A amount in saliva before applying hawley retainer
Time frame: 1 day after debonding and before retention appliance to 1 month.
The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
Results publication: PubMed 28257731Raghavan AS, Pottipalli Sathyanarayana H, Kailasam V, Padmanabhan S. Comparative evaluation of salivary bisphenol A levels in patients wearing vacuum-formed and Hawley retainers: An in-vivo study. Am J Orthod Dentofacial Orthop. 2017 Mar;151(3):471-476. doi: 10.1016/j.ajodo.2016.07.022.
Results publication: PubMed 30477778Manoj MK, Ramakrishnan R, Babjee S, Nasim R. High-performance liquid chromatography analysis of salivary bisphenol A levels from light-cured and chemically cured orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):803-808. doi: 10.1016/j.ajodo.2018.02.008.
Results publication: PubMed 21300247Eliades T, Voutsa D, Sifakakis I, Makou M, Katsaros C. Release of bisphenol-A from a light-cured adhesive bonded to lingual fixed retainers. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):192-5. doi: 10.1016/j.ajodo.2009.12.026.
Results publication: PubMed 15803273Sasaki N, Okuda K, Kato T, Kakishima H, Okuma H, Abe K, Tachino H, Tuchida K, Kubono K. Salivary bisphenol-A levels detected by ELISA after restoration with composite resin. J Mater Sci Mater Med. 2005 Apr;16(4):297-300. doi: 10.1007/s10856-005-0627-8.
Results publication: PubMed 22133942Kang YG, Kim JY, Kim J, Won PJ, Nam JH. Release of bisphenol A from resin composite used to bond orthodontic lingual retainers. Am J Orthod Dentofacial Orthop. 2011 Dec;140(6):779-89. doi: 10.1016/j.ajodo.2011.04.022.
Results publication: PubMed 17208109Eliades T, Hiskia A, Eliades G, Athanasiou AE. Assessment of bisphenol-A release from orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2007 Jan;131(1):72-5. doi: 10.1016/j.ajodo.2006.08.013.
Individual participant dataSharing planned: No

Related trials for Orthodontic Retention

Active, not recruitingObservational study
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
Orthodontic Retainers, Tooth Mobility
Not yet recruiting
Digital vs Conventional VFR in Post-Orthodontic Retention
Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment)
Active, not recruiting
Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up
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Not yet recruiting
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The Effect of Full Versus Partial Coverage Thermoformed Retainers in Dual Retention With a Lower Bonded Retainer, on Periodontal, Orthodontic, and Patient-Reported Outcomes
Orthodontic Retention

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Orthodontic Retention, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bisphenol-A amount in saliva before applying a retainer with bis-GMA-containing composite (time frame: 1 day after debonding and before retention appliance to 1 month.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05738889, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.